NCT03634930 Josef Ressel Centre Perinatal Programming
| NCT ID | NCT03634930 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Moenie van der Kleyn |
| Condition | Childhood Obesity |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2017-02-16 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2017-02-16 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: Metabolic imprinting through early childhood nutrition seems to play an important role in the aetiology of obesity. Overweight at age two and later in life is associated with excessive weight gain as early as three months of age. Breastfeeding in the first year of life appears to be protective against obesity development. Objective: of the "Josef Ressel Centre for Early Life Metabolic Programming of Dispositions of Obesity" is to identify maternal and infant predictors of metabolic risk of obesity. The main considerations of modifiable factors are early infant nutrition, 24-hours-drinking-volume, the velocity of infant weight gain, in relation to infant fat mass and fat free mass, to biomarker and to the nutritional status of the mother. A second focus is put on maternal feeding style, infant eating behaviour and the identification of satiety cues. Multi-Study design: a monocentric prospective longitudinal cohort of 100 healthy, non-obese, non-smoking pregnant mothers and their term, normal birthweight, singleton babies. Mothers and exclusively breastfed versus exclusively formula fed children (at 16 weeks) will be examined at 36 weeks of pregnancy, 4 - 8 - 12 and 16 weeks of life, follow-up at 1 and 2 years of life. Methods: four weighing protocols between 4th and 16th week of life, feeding diary, anthropometric data measurement of mother and child, child fat mass index by air displacement plethysmograph. Macronutrient and energy content of the breast milk will be analysed by MIRIS™. Well-defined biomarkers of oxidative stress and inflammation, lipid profile, adipokines, insulin, as well as micro- und macronutrients will be analysed as meaningful indicators regarding the development of obesity and/or the metabolic syndrome in newborns. Samples, such as plasma, urine, saliva, and stool of the mothers and children will be examined with High Performance Liquid Chromatography, High Performance Gas Chromatography, Mass Spectrometry, Enzyme-Linked Immunosorbent Assay (ELISA) and more. Also questionnaires for the evaluation of the maternal milk feeding style are used as well as the Baby and Child Eating and Behaviour Questionnaire at 16 weeks, 1 and 2 years. A semi-automatic recognition of infants' satiety cues during feeding will be performed. The recording environment includes video cameras and microphones, a pulse oximeter, etc. All signals are synchronously recorded with the aid of the hardware and software infrastructure.
Eligibility Criteria
Inclusion Criteria: 1. Pregnancy or mother in puerperium 2. Delivery of baby at 37+0 to 41+6 gestational age 3. Legal age (18 years old), age limit 50 years 4. Written consent of test person after having been informed 5. BMI ≥ 18.5 kg/m² to \< 30 kg/m² 6. Negative result of oGTT (oral glucose tolerance test) during pregnancy 7. Birth weight of baby 2.5-4.5 kg 8. Non-smoker since knowledge of pregnancy 9. Very good knowledge of German language and Caucasian 10. Exclusive breastfeeding or exclusive formula feeding at MR 2 (4th week of life) Exclusion Criteria: 1. Birth before 37+0 week of pregnancy (WoP) or after the 41+6 WoP 2. Multiple pregnancy 3. Children with serious congenital malformations of * Nervous system * Mouth, throat, neck * Circulation system * Respiratory tract * Gastrointestinal tract * Urogenital tract * Chromosomal aberrations 4. Diseases or hospitalization or intensive medical care of child during neonatal period 5. Hereditary metabolic diseases of child * Hereditary disorders of fat metabolism (MCHAD: Medium Chain Acyl-CoA Dehydrogenase Deficiency, LCHAD: Long Chain Acyl-CoA Dehydrogenase Deficiency, VLCHAD: Very Long Chain Acyl-CoA Dehydrogenase Deficiency) * Hereditary disorders of amino acid metabolism (PKU: Phenylketonuria) * Hereditary disorders of carbohydrate metabolism (Glycogenosis, Galactosemia, Hereditary fructose intolerance, Diabetes mellitus Type 1) 6. Drug (tobacco) abuse 7. Mental illnesses that have to be treated with medicaments 8. Metabolic or autoimmune diseases of mother 9. Complications at birth (blood loss \> 1000 ml or eclampsia) 10. Pre-conceptional diabetes (type 1 or 2) 11. Celiac disease and/or wheat protein allergy of mother 12. Breast surgery and/or hypomastia 13. Mixed feeding at MR 2 (4th week of life)
Contact & Investigator
Moenie van der Kleyn, MPH
STUDY DIRECTOR
FH Joanneum Hebammen
Frequently Asked Questions
Who can join the NCT03634930 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Childhood Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03634930 currently recruiting?
Yes, NCT03634930 is actively recruiting participants. Contact the research team at moenie.vanderkleyn@fh-joanneum.at for enrollment information.
Where is the NCT03634930 trial being conducted?
This trial is being conducted at Graz, Austria.
Who is sponsoring the NCT03634930 clinical trial?
NCT03634930 is sponsored by Moenie van der Kleyn. The principal investigator is Moenie van der Kleyn, MPH at FH Joanneum Hebammen. The trial plans to enroll 100 participants.
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